Turkey: Honorarium Payments To Healthcare Professionals

Pharmaceutical companies, physicians, pharmacists, academicians,
pricing and reimbursement officers... Each of these is an important
stakeholder, who has a critical role in presenting the most
effective treatments to patients. In that respect, all of these
interact with each other under certain rules and regulations. One
example is that pharmaceutical companies, who are the marketing
authorisations holders of pharmaceutical products, need to receive
professional assistance of healthcare professionals as well as key
opinion leaders, academicians and other specialists (all will be
referred to as "HCPs") in the process of
developing medical content and disseminating such information to
other HCPs.

The most frequent forms of the professional assistance received
from HCPs are speaker services and advisory services. In the first
one, HCPs attend scientific symposia and congresses to deliver
speech and presentation on a scientific topic, while on the other
such contribute in preparation of a medical content or material. In
return of the professional services provided and the time
allocated, a fee called "honorarium fee" is paid.

All over the world, interactions between HCPs and pharmaceutical
companies is a debated area. To prevent any conflict of interest,
official authorities and public expect more transparency. In that
respect, governments do their best to minimise the financial
interactions. As detailed below, this is also what has happened in
Turkey as the Government through the law making process before the
Turkish Parliament amended the legislation to prevent such
interactions as much as possible.

Although it may be understandable why such a sceptical approach
is taken, it should also be taken into account that such medical
advisory services are necessary indeed not only for pharma
companies and physicians but also in the ultimate plan the public,
as public has the utmost right and benefit in developing the
medical intellectual capacity in the pharmaceutical area.

Surely, also the pharma industry supports that this area is
regulated by certain rules and regulations. In particular,
originator pharmaceutical companies, which are foreign capital
companies and in most cases do care about complying crossborder
legislation such as FCPA, UK Anti-bribery Act, are willing to take
all the necessary precautions to prevent any breach to the local
legislation and ethics rules.

In the light of the foregoing, we have deemed necessary to
provide information on the current legal status regarding
honorarium payments.

1. Current Legal Framework in Turkey

Currently working conditions of HCPs and honorarium payments
made to HCPs are stipulated under the Decree Law with No. 650
published in the Official Gazette on August 26, 2011. The Decree
Law with No. 650 amended various laws including the following:

Law on Public Servant, No. 657, Article 28: Public servants
cannot operate bureaus, offices and private clinics to perform
professional activity or self-employed work; neither can they work
at workplaces of private entities or institutions in the nature of
public institution or foundation universities.

Law on Higher Education, No. 2547, Article 36: Academics (only
professors and assistant professors) can perform professional work
after working hours, provided that they do not receive revenue from
the revolving fund administrations of their institutions.

Law on Military Medicine Academy Law, No. 2955, Article 32:
Academic personnel of the civil and armed forces (only professors
and assistant professors) can perform professional work after
working hours, provided that they do not provide services at their
institutions regarding treatment of soldiers and they have obtained
permission from the Turkish General Staff.

In accordance with the mentioned amendments, the Decree Law with
No. 650 stipulated a restrictive approach with respect to HCPs
working on his/her account. In summary, all public officers were
prohibited from working on their own account both during and after
working hours, however, physicians with academic status (civilian
or soldier) could work on their own behalf provided that they do
not generate income from revolving fund of the institution that
they work and they performed such study after working hours.
Another controversial dimension of the matter was related to
copyright payments. We evaluate that copyright payments that could
be made to HCPs should be literally interpreted, since an
intellectual or artistic work must exist in order to make a
copyright payment. We evaluate that in case HCPs who are public
officers and HCPs with academic title who created a work, which has
no relationship with the official duty of the HCP, copyright
payment could be directly made to the HCP.

However, the Constitutional Court repealed the Decree Law with
No. 650 a year after its publication, on July 2012. Nevertheless,
the repeal decision is not yet published on the Official Gazette,
and will enter into force one year following its publication. The
grounds of the repeal decision are the procedural rationales. The
Court did not state any evaluation with respect to substantial
aspects of the Decree Law. Therefore, we evaluate that the decision
did not change the current legal status with respect to payments
made to HCPs.

2. Transparency with regard to the Relationships between
Pharmaceutical Companies and HCPs

Meanwhile in Europe, the pursuit for transparency with regard to
the relationships between pharmaceutical companies and HCPs has
also been a topic of discussion. The Directive 2001/83/ EC of the
European Parliament and the Council dated November 6, 2001 relating
to Medicinal Products for Human Use ("Directive"),
concentrates on many aspects of the promotion of medicinal
products. However, the Directive does not comprise any provision
regarding disclosure or reporting requirements on (honorarium)
payments to HCPs. Therefore, EU member states are not required to
regulate any such obligations in their national laws, but some
European countries regulate this area. For instance, the French
government enacted a transparency act, namely "La Loi
Relative au Renforcement de la Sécurité Sanitaire du
Médicament et des Produits de Santé" (The
law relating to improvement of the health security of drugs and
healthcare product) in December 2011 which was deemed as a major
and comprehensive reform of the French healthcare system. This act
stipulates reporting requirements and two main types of
transparency rules; (i) public declarations of interest that HCPs
must make concerning their relationship with pharmaceutical
companies, and (ii) disclosure obligations imposed on
pharmaceutical companies concerning their interactions with
HCPs.

In the meantime, the European Federation of Pharmaceutical
Industries and Associations (EFPIA), of which Association of
Research-Based Pharmaceutical Companies (AIFD) is a member,
released the Code on Interactions with Healthcare Professionals,
which does not contain actual reporting or disclosure requirements.
However, it encourages pharmaceutical companies to ensure that
information, regarding donations, grants or benefits provided to
institutions, organisations or associations comprised of HCPs, are
publicly available. Furthermore, the EFPIA Code on Relationships
with Patient Organisations contains reporting requirements. The
requirements apply to activities initiated as of or ongoing on
January 1, 2012, with the first reports to be made public by the
end of the first quarter of 2013.

Finally and most recently, EFPIA Draft Code on Transparency of
Payments to HCPs and Healthcare Organisations has been prepared and
discussed. With the virtue of this Code of Transparency, EFPIA is
preparing to require member associations to impose a requirement to
document and disclose payments and other transfers of value
directly or indirectly for the benefit of the HCPs and healthcare
organisations. The Disclosure is designed to be made annually and
standardised templates shall be used.

The Ministry of Health has recently mimicked the EFPIA's
Draft Code of Transparency's approach. On October 14, 2012 the
MoH published amendments on the Regulation on Promotional
Activities of Human Medicinal Products and required HCPs to
mention/disclose all sorts of sponsorships received at the end of
each scientific article and/or at the beginning of every speech/
presentation.

3. Conclusion

As summarised above, we are in a transition period where the
issue of honorarium payments seems to be debated for a further
while. The legislation will be amended at some point in light of
the Constitutional Court decision. However, we evaluate that there
are already certain rules in place to be considered in determining
the necessary actions to be taken. Therefore, it would be
reasonable to follow the wording and the spirit of such rules and
prefer to remain on the safe side to avoid any possible
administrative and/or legal risk.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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